- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055870
Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy
June 25, 2021 updated by: Methodist Health System
The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).
This is a clinical quality improvement (CQI) initiative to evaluate outcomes within our institution.
The data collected will be used to inform new innovative ways to improve EUS-guided liver biopsy with an ultimate goal of improving the quality of patient care.
The clinical outcomes of this patient population have not been previously systematically reviewed in MDMC.
Currently, the procedure in not being performed routinely at Methodist Dallas Medical Center (MDMC).
However, with new technical and physician expertise, this option is now available at our institution.
PI will evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients requiring histologic examination of their liver at MDMC.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75203
- Methodist Dallas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Age 18 years or older and have undergone EUS-guided liver biopsy at MDMC
Description
Inclusion Criteria:
- Age 18 years or older
- Undergone EUS-guided liver biopsy at MDMC
Exclusion Criteria:
- Below 18 years of age
- Did not undergo EUS-guided liver biopsy at MDMC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Undergone EUS-guided liver biopsy at MDMC
|
Endoscopic ultrasound (EUS) guided liver biopsy sampling is emerging as an alternative to the aforementioned approaches that offers several advantages, including decreased sampling variability and procedure-related complications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of core biopsy
Time Frame: 9/1/2017 and 9/1/2019
|
9/1/2017 and 9/1/2019
|
|
Number of portal tracts
Time Frame: 9/1/2017 and 9/1/2019
|
9/1/2017 and 9/1/2019
|
|
Diagnostic yield
Time Frame: 9/1/2017 and 9/1/2019
|
We will define an adequate specimen as one containing ≥11 portal tracts or measuring ≥20 mm cumulative core length.
|
9/1/2017 and 9/1/2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prashant Kedia, MD, Methodist Dallas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2017
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 14, 2019
Study Record Updates
Last Update Posted (Actual)
June 28, 2021
Last Update Submitted That Met QC Criteria
June 25, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 045.GID.2017.D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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